Hyperpolarized 13C-pyruvate Metabolic MRI With Infiltrating Gliomas

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
University of Maryland, Baltimore
Study ID
NCT04772456
Phase
PHASE1
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Hyperpolarized 13C-Pyruvate — DRUG
    Hyperpolarized Pyruvate (13C) Injection, containing spin-polarized ("hyperpolarized") \[ 13C\]pyruvate, is being studied as a diagnostic agent in combination with 13C spectroscopic MR imaging. The aim is to visualize \[13C\]pyruvate and its metabolites and thereby distinguish between anatomical areas with normal vs. abnormal metabolism, which should be useful in diagnosing and characterizing, for example, malignancy. Hyperpolarized Pyruvate (13C) Injection and \[13C\]pyruvate are general terms used throughout this brochure, that refer to all 13C labeling patterns, such as \[1- 13C\]pyruvate, \[2- 13C\]pyruvate and \[1,2- 13C\]pyruvate. From biological and safety standpoints, pyruvate with each of the labeling patterns behaves identically in the human body \[Koletzko et al., 1997\].

Study Details

The purpose of this study is to examine the safety and feasibility of performing hyperpolarized metabolic MRI in the diagnosis of brain tumor. This study will also assess the accuracy of hyperpolarized metabolic MRI to diagnose intermediate to patients with infiltrating gliomas and examine the added utility of metabolic MRI over standard MRI imaging The FDA is allowing the use of hyperpolarized \[1-13C\] pyruvate (HP 13C-pyruvate) in this study. Up to 5 patients may take part in this study at the University of Maryland, Baltimore (UMB).

Key Dates

Start date
Aug 11, 2020
Status verified
Sep 2025
Primary completion
Aug 31, 2026
Completion
Dec 31, 2027

Study Design

Enrollment
5 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: metabolic MRI
    Single-arm study in patients who have Glioma Perform metabolic magnetic resonance imaging on patient have a Glioma cancer to understand if metabolic MRI can be safely performed on this population

Primary Outcome Measure

Accuracy of metabolic MRI to diagnose Glioma [ Time Frame: Within three years post treatment ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Rosy Njonkou TchoquessiBaltimoreMaryland21201
Rosy Njonkou Tchoquessi
[email protected]
4107066445

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Rosy Njonkou Tchoquessi· Baltimore, MD

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